Suturing devices and methods for suturing an anatomic structure

ABSTRACT

Suturing devices and systems used to close openings into a biological structure. The suturing device can comprise an elongate member having a proximal end, a distal end, one or more arms, and one or more needles. One or more sheaths may be used with the device to maintain or substantially maintain haemostasis while the device is used and while a procedure is performed in the biological structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/400,309 filed Nov. 10, 2014, titled “SUTURING DEVICES AND METHODS FORSUTURING AN ANATOMIC STRUCTURE”, which is a U.S. National Phase ofInternational Patent Application No. PCT/US2013/040418, filed May 9,2013, titled “SUTURING DEVICES AND METHODS FOR SUTURING AN ANATOMICSTRUCTURE”, which claims priority to U.S. Provisional Application No.61/779,901, filed Mar. 13, 2013; U.S. Provisional Application No.61/715,123, filed Oct. 17, 2012; and U.S. Provisional Application No.61/646,188, filed May 11, 2012, the contents of all of which are herebyincorporated by reference herein.

TECHNICAL FIELD

Embodiments of the present invention relate to suturing devices andmethods. Some embodiments relate to suturing devices and methods forsuturing an anatomic structure, such as a heart.

BACKGROUND

Health practitioners frequently use sutures to close various openingssuch as cuts, punctures, and incisions in various places in the humanbody. Generally, sutures are convenient to use and function properly tohold openings in biological tissue closed thereby aiding in bloodclotting, healing, and prevention of scarring.

There are some circumstances under which it is not feasible to useconventional sutures and suturing methods to close an opening.Additionally, there are some circumstances under which the use ofconventional sutures and suturing methods require invasive proceduresthat subject a patient to risk of infection, delays in recovery,increases in pain, and other complications.

SUMMARY OF THE DISCLOSURE

Embodiments of suturing devices used to suture closed openings into abiological structure while maintaining or substantially maintaininghaemostasis are described herein. The suturing devices and methods canalso be used to place sutures prior to a surgical procedure and toprepare access for the procedure while maintaining or substantiallymaintaining haemostasis. The placed sutures can then be used to tightenan opening while any devices or tools are withdrawn, closing the openingwhile the final device or tool leaves the opening such that the openingis never without a device or tool inside it during the course of theprocedure.

In the embodiments described herein, the disclosed devices are used toplace sutures to close an opening into a heart, although they are notlimited to applications within a heart. The heart can be accessedthrough a sternotomy or limited thoracotomy, or alternatively the devicecan pass through a trocar or other element into the thoracic cavity andthen be led toward the opening in the heart, typically by following aguide wire. In some embodiments, the opening is a puncture made at ornear the apex of the heart. The puncture can also be made at other areasof the heart. In some embodiments, suturing devices and methodsdisclosed herein can be used to minimize the collection of fluid betweenthe heart and the pericardial sac that surrounds the heart.

In some embodiments, a suturing system can include a suturing devicehaving an elongate body with a proximal end and a distal end, and aplurality of arms near the distal end. Each arm can be configured tomove between a first position in which the arm is retracted within theelongate body and a second position in which the arm has a free endextending away from the elongate body. Each arm can have at least onesuture mount at the free end. The device can also have a plurality ofneedles, each needle configured to move between a retracted position inwhich the needle is within the elongate body to a deployed position inwhich the distal point of the needle extends out of the elongate bodyand into a corresponding suture mount.

The system can also include a first sheath adapted to surround at leasta portion of the elongate body, a second sheath adapted to surround atleast a portion of the first sheath, and a plurality of suture portions.Each suture portion can have a suture end releasably retained within asuture mount of a corresponding arm, and each suture portion can extendfrom a corresponding suture end, between the first sheath and the secondsheath, to a position proximal to at least the second sheath.

Methods of use are also described. In some embodiments, a suturingsystem can be delivered through a heart wall, and the suturing systemcan include a suturing device with an elongate body having a proximalend and a distal end, the suturing device also having a distal sectionthat extends through the heart wall and into the heart once the suturingsystem is delivered. The suturing device can also have a plurality ofarms positioned outside of the heart and a plurality of needlespositioned inside the heart once the suturing system is delivered. Thesuturing system can also include a first sheath positioned over thesuturing device, a distal end of the first sheath being proximal to theplurality of arms once the suturing system is delivered, and a secondsheath positioned over the first sheath.

The plurality of arms can be extended from the elongate body of thesuturing device, each of the arms carrying a suture portion having asuture end releasably retained in a respective arm, each suture portionextending from its respective arm proximally between the first sheathand the second sheath to a location outside of the patient. Theplurality of arms can be positioned against the outside surface of theheart, and the plurality of needles can be advanced from the elongatebody through the heart wall, each needle aligned with a respective armand engaging a respective suture end carried by the respective arm. Theplurality of needles can be retracted through the heart wall to draw therespective suture ends through the heart wall and the arms can beretracted into the elongate body of the suturing device whilemaintaining a distal section of the elongate body within the heart. Thefirst sheath positioned around the elongate body can be advanced intothe opening in the heart wall and the elongate body can be withdrawnfrom the heart wall while leaving the first sheath within the heartwall, the withdrawing of the elongate body drawing the suture endsengaged by the needles through a lumen of the first sheath to a locationoutside of the patient.

In some embodiments, a suturing device for suturing an opening in aheart wall can include an elongate body with a proximal end and a distalend, a first section at the distal end, a second section proximal to thefirst section, and a distally facing body surface between the first andsecond sections. The second section can have a larger outer dimensionthan the first section and the distally facing body surface can beconfigured to press against an external surface of a heart when thefirst section is advanced into the opening in the heart. The device canalso include a plurality of arms near the distal end in the secondsection, each arm configured to move between a first position whereinthe arm is retracted within the elongate body, and a second positionwherein the arm has a free end extending away from the elongate body.Each arm has at least one suture mount at the free end and configured toreleasably retain a suture portion. The device can also include aplurality of needles, each needle configured to move between a retractedposition in which the needle is within the elongate body to a deployedposition in which a distal point of the needle extends out of theelongate body and into a suture mount.

In some embodiments, an elongate device can be delivered through a heartwall such that a distal section of the device is positioned within theheart. Fluid exiting the heart along the distal section of the elongatedevice and through the heart wall can be removed. The removal caninclude the step of causing the fluid to flow through at least oneopening positioned on the elongate device on an outside of the heart toremove fluid that may accumulate between the outside of the heart andthe pericardial sac.

In some embodiments, a suturing device can include an elongate body witha proximal end and a distal end, the distal end of the elongate bodyconfigured to be delivered through a heart wall into a heart. The devicecan also include a plurality of arms near the distal end, each armconfigured to move between a first position in which the arm isretracted within the elongate body and a second position in which thearm has a free end extending away from the elongate body. Each arm canhave at least one suture mount at the free end and configured toreleasably retain a suture portion. Each arm can also have a proximalside configured to engage the pericardial sac as the arm moves from thefirst position to the second position, and each arm in its secondposition can be configured to be positioned along an outer surface ofthe heart. The device can also include a plurality of needles, eachneedle configured to move between a retracted position in which theneedle is within the elongate body to a deployed position in which adistal point of the needle extends out of the elongate body and into asuture mount, passing through the heart wall when the arms arepositioned along an outer surface of the heart.

In some embodiments, a suturing device having an elongate body can bedelivered through a heart wall such that a distal section of the deviceis positioned within the heart. The device can have a plurality of armsand a plurality of needles, and each arm can be moved from a firstposition wherein the arm is retracted within the elongate body to asecond position wherein the arm has a free end extending away from theelongate body. The arms can engage the pericardial sac and move it awayfrom an outer surface of the heart as they move to their secondpositions. Each arm can have at least one suture mount at the free endreleasably retaining a suture portion, and the plurality of needles canbe moved from a retracted position in which needles are within theelongate body to a deployed position in which distal points of theneedles extend out of the elongate body, through the heart wall and intoa suture mount of a corresponding arm.

In some embodiments, an opening in a heart can be closed by insertingfour sutures through tissue of the heart wall such that each suture hasan end that runs through the opening in the heart and an end that runsoutside of the heart. The four sutures can include a first pair and asecond pair of sutures, and the sutures of the first pair can bepositioned opposite each other with respect to the opening in the heartand the sutures of the second pair can be positioned opposite each otherwith respect to the opening in the heart. A first pledget can beattached to a first end of a first suture and a second pledget can beattached to a first end of a second suture, where the first suture and athird suture make up the first pair, and the second suture and a fourthsuture make up the second pair. The ends of the first pair that runthrough the opening of the heart can be secured together, and the endsof the second pair that run through the opening of the heart can besecured together. At least one of the ends that run outside the heart ofeach pair can then be pulled.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features disclosed herein are describedbelow with reference to the drawings of specific embodiments. Theillustrated embodiments are intended for illustration, but notlimitation. The drawings contain the following figures:

FIG. 1A is a perspective view of one embodiment of a suturing device.

FIG. 1B is a perspective view of a distal assembly of one embodiment ofa suturing device.

FIG. 2 is a perspective view of a portion of a suturing device showingsuture arms in a retracted position and with certain external componentsnot illustrated.

FIG. 3 is a perspective view of a portion of a suturing device showingsuture arms in an extended position and with certain external componentsnot illustrated.

FIG. 4 is a perspective view of a portion of a suture device showingneedles, and with certain external components not illustrated.

FIG. 5 is a cross sectional view of a portion of a suturing device usedto lock needles to a drive tube.

FIG. 6 is a transparent view of a portion of the distal assembly.

FIG. 7 is a cross sectional view of a distal assembly taken along theline 7-7 of FIG. 6.

FIG. 8 is a cross sectional view of one embodiment of a distal assembly.

FIG. 9A is a perspective view of a section of one embodiment of a distalassembly.

FIG. 9B is a top view of the second of FIG. 9A.

FIG. 10 is a cross sectional schematic representation of the device ofFIG. 1 passing through an opening at the apex of a heart.

FIG. 11 is a schematic representation as in FIG. 10 showing arms of thedevice in contact with the heart.

FIG. 12 is a schematic representation as in FIG. 11 showing suture catchmechanisms engaging suture clasps.

FIG. 13 is a schematic representation as in FIG. 12 showing the suturecatch mechanisms retracted into the device and suture portions extendingthrough the heart wall.

FIG. 14 is a schematic representation as in FIG. 13 showing the devicepartially withdrawn from the heart.

FIG. 15 is a schematic representation as in FIG. 14 showing arms of thedevice in a retracted position.

FIG. 16 is a schematic representation as in FIG. 15 showing a firstsheath advancing and the device withdrawing from the heart.

FIG. 17 is a schematic representation as in FIG. 16 showing the devicewithdrawn and the first sheath advanced into the heart wall.

FIG. 18 is a schematic representation as in FIG. 17 showing suture endspassing through a trocar inserted into a chest wall.

FIG. 19 is a schematic representation as in FIG. 18 showing a sutureportion pulled into the heart.

FIG. 20A is a schematic view of one embodiment of a threader.

FIG. 20B is a schematic view of a pledget having been threaded with thethreader of FIG. 20A.

FIG. 21A is a schematic view of one embodiment of a threader.

FIG. 21B is a schematic view of a pledget having been threaded with thethreader of FIG. 21A.

FIG. 22 is a schematic perspective view of a portion of a heart withfour separate sutures running through heart tissue.

FIG. 23A is a schematic view of the portion of the heart of FIG. 22 withtwo pledgets attached to sutures according to one embodiment.

FIG. 23B is a schematic view of the portion of the heart of FIG. 22 withtwo pledgets attached to sutures according to one embodiment.

FIG. 24A is a schematic view of pledgets arranged according to theembodiment of FIG. 23A.

FIG. 24B is a schematic view of pledgets arranged according to theembodiment of FIG. 23B.

FIG. 25 is a side view of a distal assembly of one embodiment of asuturing device.

FIG. 26 is a cross sectional schematic representation of the device ofFIG. 25 passing through an opening at the apex of a heart with armsextended.

FIG. 27 is a cross sectional schematic representation of the device ofFIG. 25 passing through an opening at the apex of a heart with armsretracted.

FIG. 28 is a schematic representation as in FIG. 27 showing the armsextended.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

Embodiments of suturing devices used to suture closed openings into abiological structure while maintaining or substantially maintaininghaemostasis are described herein. The suturing devices and methods canalso be used to place sutures prior to a surgical procedure and toprepare access for the procedure while maintaining or substantiallymaintaining haemostasis. The placed sutures can then be used to tightenan opening while any devices or tools are withdrawn, closing the openingwhile the final device or tool leaves the opening such that the openingis never without a device or tool inside it during the course of theprocedure.

In the embodiments described herein, the disclosed devices are used toplace sutures to close an opening into a heart, although they are notlimited to applications within a heart. In some embodiments, the openingis a puncture made at or near the apex of the heart. The puncture canalso be made at other areas of the heart. The heart can be accessedthrough a sternotomy or limited thoracotomy, or alternatively the devicecan pass through a trocar or other element into the thoracic cavity andthen be led toward the puncture in the heart, typically by following aguide wire.

A heart is surrounded by a pericardial sac (or pericardium), and inorder to puncture into the heart the pericardium must also be puncturedor cut and moved out of the way. Accessing the heart in this mannerpresents a risk that blood may leak through the opening and collectbetween the pericardium and the heart wall. This blood can put pressureagainst the heart and in some cases can cause a cardiac tamponade. Insome embodiments described herein, the device can be used to limit therisk of blood collecting between the pericardium and the heart wall.This can be achieved by creating a space outside of the heart whereblood can collect without running between the pericardium and the heart,and by creating a flow path from the space and into the device. In someembodiments, a negative pressure can be used to draw blood from thespace and into the device.

In some embodiments described herein, the device can be used to limitthe risk of blood collecting between the pericardium and the heart wallby suturing the opening closed with sutures that pass through the heartwall but not through the pericardium. The pericardium can thereby remainloose around the heart wall, blood can more easily drain out, and thepericardium can be sutured closed after blood has drained out.

In some embodiments, the suturing devices can be used to close or reducea variety of other tissue openings, lumens, hollow organs or natural orsurgically created passageways in the body. In some embodiments, thesuturing devices can be used to suture prosthetics, synthetic materials,or implantable devices in the body. For example, the devices can be usedto suture a pledget within the body.

Further details of suturing devices and methods that may be used tosuture an opening in a heart can be found in U.S. Patent Publication No.2011/0190793 A1, published Aug. 4, 2011, which is hereby incorporated byreference in its entirety. Features and procedures described in theaforementioned publication can be incorporated into the embodimentsdescribed herein.

FIGS. 1A and 1B illustrate perspective views of one embodiment of asuturing device 1. FIG. 1A is an embodiment of the entire device, andFIG. 1B illustrates a section of a distal assembly 2 of the device. Thedevice can be used to insert sutures through the outer wall of a heartin anticipation of a surgical procedure within the heart, whilemaintaining haemostasis. The device has a proximal and a distal end. Atthe distal end, the device can have a guide wire lumen 8, which canallow the device to follow a guide wire to a desired position. At theproximal end, the suturing device can comprise one or more handles 7with various mechanisms that can be used to control the elements of thedistal assembly. Further details regarding handles and associatedcomponents, including actuator rods, are provided in U.S. PatentApplication Publication No. 2008/0269786, published on Oct. 30, 2008,which is hereby incorporated by reference herein in its entirety.

The device can comprise an elongate body 3 which can include a pluralityof suture arms 20. The suture arms 20 can move from a retractedposition, as illustrated, in which the suture arms are at leastpartially within the elongate body 3, to an extended position, describedand illustrated below in which the suture arms extend outward from theelongate body. The suture arms can also be positioned at varying anglesfrom each other around the circumference of the elongate body. Theillustrated embodiment has four suture arms 20 spaced 90 degrees apart.In some embodiments, there may be more suture arms spaced varyingdegrees apart. In some embodiments, there may be just one suture arm,which can be rotated about an opening in the heart to place multiplesutures around the opening. For purposes of closing the opening, it canbe desirable to have an even number of suture arms, such as 2, 4, 6, or8, each suture arm part of a pair with another suture arm spaced 180degrees apart around the circumference of the elongate body. In someembodiments, the device can also have an odd number of suture arms. Ifjust a single suture arm is used to position multiple sutures around theopening, the sutures can be positioned in pairs spaced 180 degrees apartaround the opening.

The suture arms 20 can comprise one or more suture mounts or clasps 22at a distal end. The suture clasps 22 can be adapted to releasablyretain a suture portion 30. In some embodiments, the suture clasps canreleasably retain a suture portion 30 while the suture arms 20 are inthe retracted position and in the extended position. In someembodiments, as illustrated, the suture clasps may not retain a sutureportion until the suture arms move toward the extended position. In someembodiments, a suture end may be retained in the suture clasps. In someembodiments, the suture clasps may retain a portion of suture that isnot the suture end.

When the device is assembled, it can be pre-loaded with a first sheath 4(for example an 18 french sheath) that surrounds at least a portion ofthe elongate body and a second sheath 5 surrounding at least a portionof the first sheath 4. In some embodiments, as illustrated, a distal endof the first sheath 4 can extend to a position just proximal to thesuture arms, thereby allowing the suture arms to move into the extendedposition or into the retracted position. The suture portions 30 can runoutside of the first sheath 4 and through the second sheath 5 to aposition proximal to at least the second sheath 5. The second sheath canhelp confine the suture portions such that they do not get tangled orotherwise interfere with a procedure, described below. In someembodiments, the second sheath 5 is shorter than first sheath 4. In someembodiments, the second sheath 5 can be a peel-away sheath that can beremoved from around the first sheath and around the suturing device.

The device can also include suture catch mechanisms (referred to hereinas needles), described below, that can retrieve sections of suture fromthe suture clasps 22. In some embodiments, the device can include one ormore needle exit channels 26, from which the needles can exit aninterior of the elongate body 3 in order to reach the suture clasps 22.In some embodiments, there can be an equal number of needle exitchannels 26 as there are suture arms 20, and the needle exit channelscan be configured to align with a corresponding suture arm.

FIGS. 2 and 3 illustrate the suture arms 20 in more detail. FIG. 2 is aperspective view of a portion of the device with certain externalcomponents not illustrated in order to improve visibility. The devicecan have a suture arm driver 23, to which the suture arms 20 canrotatably attach at a first end thereof. The suture arms can be free ata second end opposite the first end, allowing the second end to swingoutward such that the arms can move from the retracted position to theextended position, or to swing inward such that the arms can move fromthe extended position to the retracted position.

As illustrated, the suture arms 20 can rotate about a proximal end ofthe suture arm. In some embodiments, the suture arms can slide or movein other ways from the retracted to the extended position, or from theextended to the retracted position. In the illustrated embodiment, asthe suture arms 20 rotate from the extended to the retracted position,the suture clasps 22 will move toward a distal end of the suturingdevice. In some embodiments, the suture arms can be configured such thatthe suture clasp moves distally as the arms rotate from the retracted tothe extended position. In some embodiments, the suture arms can rotateabout a distal end of the suture arm.

In some embodiments, as illustrated in FIG. 2, the suture arm driver 23can translate along a central shaft 80. As it translates it can move thesuture arms 20 with it. In some embodiments, the suture arm driver cantranslate far enough such that the suture arms can contact a section 81of the elongate body 3, as illustrated. In some embodiments, the section81 of the elongate body contacted by the suture arms can be angled. Theends of the suture arms opposite the suture arm driver can also have anangled surface 21, and as the suture arm driver moves farther toward thesection 81 the suture arms 20 will be pushed outward toward the extendedposition. To move the arms from the extended position to the retractedposition, the suture arm driver 23 can translate along the central shaft80 in the opposite direction, and the suture arms 20 can return to theretracted position.

FIG. 3 is a perspective view of a section of the distal assembly 2 withcertain external components not illustrated in order to improvevisibility. FIG. 3 illustrates one embodiment of the suture arms 20 inan extended position. In some embodiments, the suture arms 20 can begenerally straight. In some embodiments, the suture arms 20 can extendfrom the elongate body at approximately 90 degrees. In some embodiments,the suture arms can extend from the elongate body at an angle less than90 degrees or greater than 90 degrees. In some embodiments, the suturearms can have angled or curved segments, and can extend from theelongate body at a first angle and have other sections at other anglesrelative to the elongate body. In some embodiments, the suture clasps 22can be on a section of the suture arms that is at an angle relative tothe elongate body that is different from the first angle.

With continued reference to FIGS. 2 and 3, in some embodiments thesuture arms 20 can each have a bumper 28. The bumpers can be positionedsuch that they provide clearance for the suture arms to rotate to orfrom the extended position. Preferably, the bumpers 28 have a curvedsurface, but in some embodiments they can have flat sections. In someembodiments, the suture clasps 22 can have a beveled or tapered section122 that is configured to receive a needle. The taper can help guide theneedles into the suture clasps and toward a suture portion within aclasp. This can be beneficial if a needle has prolapsed slightly orotherwise deviated from a preferred alignment, such as an alignment withthe center of a suture clasp 22.

FIG. 4 is a perspective view of a section of the distal assembly 2 withcertain external components not illustrated or made transparent in orderto improve visibility. FIG. 4 illustrates two needles 24 instead of fourfor clarity, but as discussed above, in various embodiments the devicecan have a different number of needles. The needles are preferablylocated distal to the suture arms 20 and preferably point proximallytoward the suture arms. In some embodiments, the needles can be locatedproximal to the suture arms and point distally toward the suture arms.The needles 24 can attach to a needle drive tube 82, which can bepositioned around the central shaft 80 and which can translate along thecentral shaft. In some embodiments, as illustrated, a collar 84 can beused to lock the needles 24 to the needle drive tube 82.

FIG. 5 illustrates a cross sectional view of one embodiment where acollar 84 is used to lock the needles 24 to the needle drive tube 82.The needles 24 can have a notch 85 adjacent one end, and the needledrive tube 82 can have a corresponding protrusion that can slot into thenotch. The collar 84 can surround both the needles and the needle drivetube, locking them into their respective positions. In some embodiments,as illustrated, the needle drive tube 82 can be narrower where itreceives the collar than in other locations of the needle drive tube.This can help seat the collar so that it does not slide further alongthe needle drive tube. In some embodiments, the needles can attach tothe needle drive tube without a collar. Also visible in FIG. 5 is thecentral shaft 80 with a guide wire lumen 8.

Returning to FIG. 4, when the needles 24 and needle drive tube 82translate along the central shaft 80, they can also translate relativeto an outer body 88. In some embodiments, the outer body 88 can havechannels 86 that can guide the needles within the outer body. Thechannels can help direct the needles and can also provide a measure ofsupport to the needles to prevent them from prolapsing or buckling. Insome embodiments, each needle can fit entirely within a respectivechannel. In some embodiments, each needle can fit partially or at leastpartially within a respective channel. Also visible in FIG. 4 is adistal sleeve 83, present in some embodiments, which can help channel aguide wire into the central shaft 80.

The needle drive tube 82 can move the needles toward or away from thesuture arms 20. As the drive tube moves the needles toward the suturearms 20 the needles will eventually reach the needle exit channels 26(visible in FIG. 1B). The needle exit channels can be angled to directthe needles toward the suture arms 20, and specifically the sutureclasps 22.

FIG. 6 is a transparent view of a portion of the distal assembly 2 whenthe needle drive tube (not visible in this figure) has moved the needles24 through the needle exit channels 26 and out of the distal assembly.Only one needle is illustrated in FIG. 6 so that the shape of the needleexit channels 26 can be more easily seen, but the illustrated embodimentwould have four needles. FIG. 7 illustrates a sectional view of thedistal assembly 2, taken along the line 7-7 visible in FIG. 6. Asillustrated in FIG. 7, in some embodiments the needle exit channels 26can extend radially outward along a line that passes through thelongitudinal axis of the distal assembly. When a needle 24 is in adeployed position passing into a corresponding suture arm 20 and suturemount 22, at least the portion of the needle external to the distalassembly can form a plane with the corresponding suture arm 20. In someembodiments, the longitudinal axis of the distal assembly can lie on theplane formed by the needle and the corresponding suture arm. In someembodiments, the plane formed by at least the portion of the needle 24external to the distal assembly 2 and the corresponding suture arm 20can be parallel to and offset from the longitudinal axis of the distalassembly. In some embodiments, the longitudinal axis of the distalassembly can be angled relative to the plane formed by the needle andthe corresponding suture arm.

FIG. 8 illustrates a cross-sectional view, similar to the view of FIG.7, of one embodiment of a distal assembly 2 with needle exit channels 26that do not extend radially outward along a line that passes through thelongitudinal axis of the distal assembly. Rather, the exit channels 26can each have a longitudinal axis that is offset from a longitudinalaxis of the distal assembly 2. This arrangement can be used withembodiments in which the longitudinal axis of the distal assembly iseither parallel to and offset from the plane formed by a needle andcorresponding suture arm, as described above, or is angled relative tothe plane.

FIGS. 9A and 9B illustrate one embodiment in which the longitudinal axisof the distal assembly is angled relative to the plane formed by atleast the portion of a needle 24 external to the distal assembly 2 andthe corresponding suture arm 20. FIG. 9A is a perspective view of asection of the distal assembly with various components removed forvisibility. FIG. 9B is a top view of the section shown in FIG. 9A. Asillustrated, the needle exit channels 26 can be arranged as in FIG. 8,and the suture arms 20 can extend radially outward along a line passingthrough the longitudinal axis of the distal assembly. As illustrated inFIG. 9A, the needle exit channels 26 are spaced or offset from a planedefined by an extended suture arm and the longitudinal axis of thedistal assembly, so that the needle 24 extends at an angle to this planeand intersects the plane at suture mount 22. As above, in someembodiments the suture arms can be symmetrically spaced about the distalassembly 2. In embodiments with four suture arms, as illustrated, theycan be spaced 90 degrees apart from each other when extended.

In some embodiments, the suture arms can each have a longitudinal axisoffset from the longitudinal axis of the distal assembly. In someembodiments, the offset for the suture arms can be the same as theoffset for the needles, and the plane formed by a needle andcorresponding suture arm can be parallel to and offset from thelongitudinal axis of the distal assembly. In some embodiments, theneedle exit channels can be arranged as in FIG. 7, the suture arms caneach have a longitudinal axis offset from the longitudinal axis of thedistal assembly, and the longitudinal axis of the distal assembly can beangled relative to the plane formed by a needle and corresponding suturearm.

In some embodiments, the needles 24 can attach to a mounting plate 87positioned around a central shaft 80 of the distal assembly. Themounting plate can have one or more cutouts 89. In some embodiments,each needle can have a notch, as described above, and the needles can bepositioned such that a notch interfaces with a cutout 89. This can atleast partially lock the needles in place, allowing relative movementbetween each needle and the mounting plate only along the length of thecutout in which the needle is positioned. In some embodiments, aretaining ring or collar 84 can be positioned around the plate to lockthe needles into position within the cutouts. In some embodiments,cutouts can be sized to substantially prevent any needle movement.

FIG. 9A illustrates the needles 24 in a deployed position in which adistal tip of each needle is within a suture mount 22. The mountingplate 87 can be configured to move along the length of the distalassembly, moving the needles with it. For example, the mounting platecan move away from the suture arms 20, pulling the needles 24 with it.In some embodiments, moving away from the suture arms can be in thedistal direction. In some embodiments, moving away from the suture armscan be in the proximal direction. When the mounting plate moves farenough, the needles can move to a retracted position in which they areentirely or substantially within the elongate body.

In some embodiments, needles 24 can have different configurations thatcan help prevent prolapse or buckling. For example, as illustrated inFIG. 9A, in some embodiments a needle 24 can include a first, proximalsection 27 with a first diameter and a second, distal section 29 with asecond diameter. In some embodiments, the second diameter can be sizedfor insertion into a suture clasp to receive a suture end. In someembodiments, the first diameter can be greater than the second diameter.The greater first diameter can help improve resistance of the needle toprolapse, buckling, or any other undesired movements. In someembodiments, the needle can transition from the first section to thesecond section between a needle exit channel 26 and a suture clasp 22.

Methods of Use

The suturing device can have a guide wire lumen, not illustrated, thatcan allow the suturing device to follow a guide wire 6 into a positionwithin the heart. In a typical procedure, a hollow needle (delivered,for example, through a trocar into the thoracic cavity) can be used topuncture an opening at or near the apex of the heart and to feed a guidewire through the opening and into the heart. The suturing device canthen follow the guide wire into the opening and into the heart. Thesuturing device can have a tapered end at the distal end of the elongatebody 3, as illustrated in FIG. 2, and the taper can be configured suchthat the device is capable of following the guide wire through theopening formed by the needle, widening the opening as the device isadvanced further into the heart. The device can then be used to place aplurality of sutures through the tissue of the heart near the opening,while maintaining or nearly maintaining haemostasis, as described below.The device can then be removed, leaving the sutures in place and thefirst sheath within the opening in the heart, thereby allowing otherdevices to be inserted through the sheath to perform a desired procedurewithin the heart. The sutures can then be used to tighten the openingclosed after the desired procedure has been performed and while thesheath and/or device is being removed.

FIGS. 10-19 illustrate one method of using the suturing device 1 toplace sutures through tissue near an opening in the heart and toposition a sheath through the opening to allow for entry of otherdevices, while maintaining or nearly maintaining haemostasis. Asdiscussed above, the device 1 can follow a guide wire 6 through apuncture in or near the apex of a heart, the tapered end of the devicewidening the opening in the heart wall 10, as the device enters furtherinto the heart. The suture arms 20 can be moved into an extendedposition, as illustrated in FIG. 10, which is a view of the device ofFIG. 1 as it enters a heart. FIGS. 10-19 show a cross sectional view ofthe heart, and only show the two arms 20 of the device that lie in theillustrated planes. Although the method illustrated in FIGS. 10-19 canbe performed with a device having only the two illustrated arms, thedescription of the method will be with reference to the device of FIG.1, which has four arms. Each suture arm 20 holds a separate suture 30,so there are a total of four separate sutures when the device ispositioned as in FIG. 10.

With the suture arms in the extended position, the device can be furtheradvanced into the heart until the suture arms press against tissue ofthe heart, as illustrated in FIG. 11. Once in position at the base ofthe heart, needles 24 can fire and extend from a distal end of theelongate body 3, through tissue of the heart, and into the suture clasps22, as illustrated in FIG. 12. In some embodiments, the device can havea needle 24 that corresponds to each suture arm, a needle thatcorresponds to multiple suture arms, or multiple needles that correspondto a single suture arm. The needles can engage the sutures 30,releasably positioned in the suture clasp, such that when the needlesretract back into the elongate body they draw a portion of suture withthem, as illustrated in FIG. 13. In some embodiments, the needles canfire simultaneously, and in some embodiments they can fire sequentially.

Once the needles have fired and drawn sutures through tissue of theheart, the device can be withdrawn slightly from the heart in order toallow the suture arms to return to a retracted position, as illustratedin FIG. 14. In embodiments where the distal ends of the suture arms moveproximally as the suture arms rotate from an extended to a retractedposition, it may not be necessary to withdraw the device prior toretracting the suture arms. Once the suture arms have been retracted, asillustrated in FIG. 15, the sutures 30 will run from within the device,through the tissue of the heart, and to a proximal end of the devicewhile passing beneath the second sheath 5 but over the first sheath 4,as illustrated in FIG. 15. The first sheath 4 can then be moved into theopening in the heart while the elongate body 3 is withdrawn, asillustrated in FIG. 16. In some embodiments, the sheath can fully passinto the opening before the elongate body has begun to be withdrawn. Insome embodiments, the elongate body can begin to be withdrawn before thesheath has entered the opening of the heart. Regardless of the order inwhich the motions occur, in order to maintain haemostasis either thesheath or the elongate body are preferably at least partially within theopening of the heart during the procedure. In FIG. 16, the sheath hasbegun to be advanced into the opening of the heart while the elongatebody has begun to be withdrawn.

In FIG. 17, the first sheath 4 has been fully advanced into the openingof the heart and the elongate body has been withdrawn. The first sheath4 can have a hemostatic valve (not illustrated) that can preventextraneous bleed back, and in some embodiments the valve can be at aproximal end of the first sheath 4. The suture ends that were within theelongate body now pass through the first sheath 4 and run to a proximalposition outside of the patient where they can be manipulated, asillustrated in FIG. 18. From the proximal position of those suture ends,the sutures run through the sheath and into the heart, through tissue ofthe heart, and back to the proximal position while remaining outside ofthe first sheath 4 and inside of the second sheath 5. The second sheath5 has been illustrated wider than in previous figures in order toimprove visibility of sutures 30 running between the first and secondsheaths. In some embodiments, the second sheath 5 can be wider ornarrower in order to have a looser or tighter fit around the firstsheath 4, and the first sheath can be wider or narrower in order to havea looser or tighter fit around the elongate body.

In FIG. 18, the second sheath 5 has been removed from around the firstsheath 4 (e.g. by peeling it off), and the portions of the sutures 30within the first sheath 4 are illustrated. FIG. 18 also illustrates theproximal end of the first sheath 4, which can be extending through atrocar 50 positioned through the chest wall 16. Each suture 30 has afree end at the proximal position outside of the patient that passesthrough the first sheath 4, into the heart, through tissue of the heart,and back to the proximal position while remaining outside of the firstsheath 4. FIG. 18 only illustrates two separate sutures 30, but theillustrated embodiment has two more sutures 30 (for a total of four)that pass through heart tissue in a plane substantially perpendicular tothe illustrated plane. Thus, there are four suture ends that passthrough the first sheath 4 and four suture ends that pass outside of thefirst sheath 4. The four separate sutures are shown schematically inFIG. 22, discussed further below. The guide wire 6 also passes throughthe first sheath 4, but it is not shown within the first sheath in FIG.18 for the sake of clarity.

Suture ends that pass through the first sheath 4 can be secured togetherwith a knot or other device. Further details regarding a device forjoining sutures are provided in U.S. Patent Application Publication No.2011/0190793, published on Aug. 4, 2011, which is hereby incorporated byreference herein in its entirety. In some embodiments, suture ends thatpass through the first sheath 4 can be secured together in pairs, eachpair having suture ends that had been releasably attached to arms 20spaced 180 degrees about the circumference of the elongate body 3 of thedevice 1. By then pulling on one or more of the remaining free sutureends, the joined suture 30 can be pulled through the first sheath 4 andinto the heart, as illustrated in FIG. 19. FIG. 19 only shows onesuture, but when the two pairs of suture ends that pass through thefirst sheath 4 have been secured together and pulled into the heart, asecond suture would pass through the heart in the plane substantiallyperpendicular to the illustrated cross section.

In some embodiments, the point where a pair of suture ends has beenjoined together can be passed through the tissue of the heart andoutside of the heart by pulling on one of the remaining free sutureends. In some embodiments, prior to joining the two suture ends thatpass through the first sheath, a pledget can be slidably attached to asuture end, such as by threading a suture end through a hole in thepledget. After the two suture ends that pass through the first sheathhave been secured together, the joined suture can be pulled through thetissue of the heart by one of the remaining free ends until the pledgetcontacts an inner surface of the heart wall, where it may remain. Insome embodiments, prior to or after joining the two suture ends withinthe sheath, a pledget can be attached to a free suture end that passesoutside of the first sheath 4. With the two suture ends within the firstsheath joined, the opposite free suture end can be pulled until thepledget contacts an outer surface of the heart, where it may remain.

FIGS. 20A-24B illustrate various methods and embodiments of closing anopening within a heart, including the use and placement of pledgets. Themethods and embodiments described herein can also be used to closeopenings in other biological structures. Thus, although the ends ofsutures are variously referred to herein as passing through or outsideof the first sheath, such descriptions can also refer respectively tosuture ends that pass through or outside of an opening in a heart orother biological structure.

In some embodiments, it can be useful to use a threader 60 to attach apledget to a suture. FIG. 20A illustrates one embodiment of a threader,which can have a handle 62 and a section extending from the handle 62 toform a collapsible loop 64 at one end. In some embodiments, the loop canbe made of wire. The loop 64 can be fed through a pledget 70, asillustrated. Also as illustrated, the loop can be fed through thepledget in two locations, though in some embodiments it can be fedthrough only one or more than two locations. A free end of suture canthen be fed through the loop and the loop can be pulled back through thepledget, bringing the suture with it. FIG. 20B illustrates a singlesuture 30 pulled through a pledget 70 in two locations. This can be doneby arranging the threader and pledget as illustrated in FIG. 20A, or byusing a threader to feed a suture through a first end of the pledget andthen using the threader to feed the suture through the second end of thepledget.

In some embodiments, a threader 60 can have a first collapsible loop 64and a second collapsible loop 66, as illustrated in FIG. 21A. In someembodiments, each loop can be passed through separate locations of apledget 70, as illustrated. A separate suture can be fed through eachloop and then pulled through the pledget, leading to the arrangement ofFIG. 21B. In some embodiments, the arrangement of FIG. 21B can beachieved by using a threader with a single loop to separately pull adifferent suture through each end of the pledget. In some embodiments, athreader can have more than two collapsible loops.

FIG. 22 illustrates a schematic of a perspective view of a portion of aheart in which a suturing device has inserted four separate suturesthrough the tissue of the heart wall 10. In some embodiments, this canbe done with a suturing device that has four arms. As discussed above, asheath, such as the first sheath 4, can be positioned at least partiallywithin the opening in the heart. A length of suture corresponding toeach arm of the device can pass from outside of the heart, throughtissue of the heart, and then through the sheath. For example, asillustrated, a first suture 32, a second suture 34, a third suture 36,and a fourth suture 38 pass through the tissue of the heart. Each suturehas a first end 32′, 34′, 36′, 38′ that passes through the sheath 4 anda respective second end 32″, 34″, 36″, 38″ that runs outside of thesheath. Pledgets can then be attached to various suture ends accordingto any method described above.

FIGS. 23A and 23B illustrate two ways in which pledgets (internalpledgets) can be attached to the first suture ends, each way yielding adifferent result when the pledgets are then pulled into the heart. FIG.23A illustrates an embodiment where adjacent suture ends that runthrough the sheath 4 are fed through opposite ends of the same pledget70. Thus, for example, the first end 32′ of the first suture 32 can befed through a first end of a pledget 70 while the first end 36′ of thethird suture 36 can be fed through a second end of the pledget 70.Similarly, the first end 34′ of the second suture 34 can be fed througha first end of a second pledget 70 while the first end 38′ of the fourthsuture 38 can be fed through a second end of the second pledget 70.

FIG. 23B illustrates an embodiment where opposite suture ends that runthrough the sheath 4 are fed through opposite ends of the same pledget70. Thus, for example, the first end 32′ of the first suture 32 can befed through a first end of a pledget 70 while the first end 34′ of thesecond suture 34 can be fed through a second end of the pledget 70.Similarly, the first end 36′ of the third suture 36 can be fed through afirst end of a second pledget 70 while the first end 38′ of the fourthsuture 38 can be fed through a second end of the second pledget 70. Insome embodiments, other arrangements of attaching suture ends topledgets can be employed.

Once the sutures have been fed through the pledgets, opposing suturesections that pass through the first sheath can be secured together andpulled into the heart, as discussed with respect to FIG. 19. Forexample, suture ends 36′ and 38′ can be secured together to form asingle suture, as can suture ends 32′ and 34′. One or more of the sutureends 32″, 34″, 36″, 38″, which run outside of the sheath 4, can then bepulled until the pledgets are brought into the interior of the heart.After a procedure is performed within the heart and the sutures aretightened to close the opening in the heart, the pledgets 70 will formdifferent arrangements depending on how they were originally placed onthe sutures.

FIGS. 24A and 24B illustrate a schematic view from inside of the heartof two different pledget placements once the opening in the heart hasbeen tightened. FIGS. 24A and 24B correspond to the pledget placement ofFIGS. 23A and 23B, respectively. As can be seen, placing the pledgetsaccording to the embodiment of FIG. 23A yields two adjacent pledgets 70.In some embodiments, the pledgets can partially overlap. The arrangementof FIG. 23B yields pledgets that cross each other, as illustrated inFIG. 24B.

In some embodiments, one or more pledgets (external pledgets) can beplaced on the second suture ends 32″, 34″, 36″, 38″, which run outsideof the sheath 4. The same placement techniques described above can beused. For example, suture ends that are located across from each othercan be fed through opposite ends of a single pledget. In suchembodiments, where four or more separate suture strands are used thepledgets can cross each other. Similarly, where adjacent suture ends arefed through opposite ends of a single pledget, the pledgets can beadjacent to each other.

The external pledgets are preferably placed on the sutures after theinternal pledgets are placed on the first suture ends 32′, 34′, 36′,38′. In some embodiments, however, the external pledgets can be placedbefore the internal pledgets are placed. In some embodiments, theexternal pledgets can be placed even if no internal pledgets are placed.Once external pledgets are placed on the lengths of suture, they can bemoved to a position adjacent heart tissue through a variety of methods.In some embodiments, external pledgets can be moved adjacent hearttissue by pulling a respective first suture end 32′, 34′, 36′, 38′before first suture ends are secured together. In some embodiments,external pledgets can be moved adjacent heart tissue by sliding asheath, catheter, or other cannulated instrument over the one or moresuture ends passing through a pledget and pushing the pledget until itis at a desired location adjacent the heart. In some embodiments, a knotplacement device, discussed below, can be used to push an externalpledget or pledgets adjacent the heart.

In some embodiments the device can have more than four suture arms. Insome embodiments, there can be more or fewer than four separate sutureswith more or fewer than four suture end portions that pass through thefirst sheath 4 and more or fewer than four suture end portions thatremain outside of the first sheath 4. It can be desirable to securetogether suture end portions that were previously attached to suturearms that were approximately 180 degrees apart around the circumferenceof the elongate body, or suture end portions that are spacedapproximately 180 degrees apart around an opening in a heart, asdiscussed above. When more than two pairs of suture end portions thatpass through the first sheath are thus joined and pulled into the heartas illustrated in FIG. 19, the result will be a first length of sutureas illustrated in FIG. 19 and two or more lengths of suture similar tothe first length but rotated about an axis of the opening in the heartwall.

Determining which of the sutures running within the sheath areapproximately 180 degrees apart can be done by pulling on the sutures tomechanically see which sutures runs through which point. In someembodiments, different colored sutures can be used to more easilydetermine which suture ends are approximately 180 degrees apart. Forexample, in an embodiment with four suture arms, the suture end attachedto a first suture arm can be a first color and the suture end attachedto a second suture arm 180 degrees about the circumference of theelongate body from the first suture arm can also be of the first color.A third suture end attached to a third arm can be of a second color, anda fourth suture end attached to a fourth arm 180 degrees about thecircumference of the elongate body from the third arm can be of thesecond color, as well. Then, when the four suture ends run through thefirst sheath, the two ends of the first color can be secured togetherand the two ends of the second color can be secured together.

Once the suture ends that pass through the first sheath 4 have beenappropriately secured and pulled into the heart, as illustrated in FIG.19, a suturing or other surgical device can be inserted through thefirst sheath 4 and into the interior of the heart. In some embodiments,prior to inserting a device into the heart, it may be desirable toreplace the first sheath with a different sheath. This can be done bystandard procedures known in the art, and can also be done whilemaintaining a sheath within the opening of the heart to thereby maintainhaemostasis. For example, an obturator may be slid over the first sheath4. The sheath 4 can then be removed, and a larger sheath may bedelivered over the obturator.

Once the desired procedure has been performed, the sheath can bewithdrawn while tightening the sutures to close the opening around thesheath as the sheath is withdrawn. In some embodiments, a tapered sheathcan be inserted prior to closing the opening, which can make it easierto close the opening tightly around the sheath as the sheath iswithdrawn from the heart. In some embodiments, a knot delivery device,such as the device mentioned above and described in U.S. PatentApplication Publication No. 2011/0190793 and incorporated by referenceherein, can be pre-loaded with the two or more of the end portions ofsutures 30 and delivered into the thoracic cavity alongside the sheath,making it easier to maintain a tightening pressure as the sheath iswithdrawn. The opening in the heart can then be closed by applying ortying a knot to the suture ends or by other known methods.

Further Device Embodiments

FIG. 25 illustrates an embodiment of a device 101 that can be used tolimit or prevent blood or other fluid from collecting between the heartand the pericardial sac that surrounds the heart. Many aspects of thedevice can function substantially the same as aspects of the devicedescribed with respect to FIGS. 1-19, even if not specificallyillustrated or described with reference to the embodiment of FIG. 25.For example, the embodiment illustrated in FIG. 25 can be used with asheath or sheaths as discussed above to place sutures through the wallof the heart and allow for performance of a procedure within the heartwhile maintaining or substantially maintaining haemostasis. Unlessdiscussed otherwise, components can be considered to have substantiallythe same function and operate in substantially the same manner assimilarly labeled components described with respect to FIGS. 1-19.

The distal end 102 of the device can have a first section 140 and asecond section 142, as illustrated in FIG. 25. The device can also haveone or more openings or holes 146 positioned at a distal end of thesecond section. The one or more openings or holes can connect to one ormore lumens that run through the proximal end of the device. In someembodiments, the lumen(s) can connect to a source of negative pressure,a stopcock, a syringe, or any other device or receptacle. In someembodiments, each of the one or more openings connects to acorresponding lumen. In some embodiments, some of the one or moreopenings connect to the same lumen.

The first and second sections are separated by a distally facing surface144, which can be formed from a step, notch, chamfer, bevel, or othergeometry between the first and second sections whereby the secondsection has a larger outer dimension than the first section. In someembodiments, the second section 142 has a cross sectional areaimmediately adjacent the surface 144 that is greater than a crosssectional area of the first section 140 immediately adjacent the surface144. As illustrated, the surface 144 is formed from a step between thefirst and second sections. The surface 144 can be at varying anglesrelative to the first and second sections such that in some embodimentsthe surface 144 is only partially distally facing, but the surface isconfigured such that when the first section 140 of the device enters anopening in the outer wall of a heart that is smaller than the secondsection 142, the surface 144 will press against the outer surface of theheart to block further entry of the device rather than expanding theopening to allow the second section 142 to enter the opening.

This mechanism can be seen in FIG. 26, which illustrates the deviceafter it has been inserted into the heart. In some embodiments a sheath(e.g. first sheath 4) can be delivered into the heart first and thenpulled back before the device is inserted into the heart. The surface144 has pressed against the outer wall of the heart, compressing itinward to form a gap or space 114. Blood that makes it out of the heartand into the space 114 can drain through the holes 146, either throughgravity or some form of negative pressure applied to the lumen(s) thatconnect to the holes 146. Consequently, blood is much less likely to endup between the pericardium 12 and the heart wall 10.

As illustrated, the arms 120 of the device are extended and pressingagainst the pericardium 12 and wall of the heart 10. The arms extendfrom the device at less than a 90 degree angle, but in some embodimentsthe arms can extend from the device at 90 degrees. As described above,the arms can releasably retain suture portions (not shown), and thedevice can comprise needles that can fire through the heart wall 10 andthe pericardium 12 to capture the suture portions, and then drawn themback through the tissue and into the device.

In some embodiments, it may be desired to have the sutures pass onlythrough tissue of the heart wall, but not through the pericardium 12.The pericardium can then be left open as a drain, it can be separatelysutured shut, or a drainage device can be installed near or within anopening in the pericardium and it can be sutured later. FIGS. 22 and 23illustrate one method of using the device of FIG. 25 to pass suturesthrough tissue of the heart but not the pericardium.

As illustrated in FIG. 27, the device can be inserted while the arms 120remain in a retracted position until the distal ends of the arms reach apoint between the pericardium 12 and an external surface of the heartwall 10. In some embodiments a sheath (e.g. first sheath 4) can bedelivered into the heart first and then pulled back before the device isinserted into the heart. As illustrated, when the device has beeninserted the surface 144 has begun to compress the heart wall when thedistal ends of the arms are between the pericardium and the externalsurface of the heart wall. In some embodiments, the arms can reach thatposition before the surface contacts the heart wall.

Once the arms are in position they can rotate to the extended position,catching the pericardium and drawing it outward, as illustrated in FIG.28. In some embodiments, the arms can have a hook, sharp edge, notch, orother structure on an outer surface of the arms that can engage with thepericardium and make it easier to draw the pericardium outward. Once thearms have been extended to a desired position, the device can beadvanced farther into the heart until the arms are against the heartwall 10. From that position, any of the procedures discussed withreference to FIGS. 10-24B can be used.

Although the foregoing description of the preferred embodiments hasshown, described and pointed out the fundamental novel features of theinvention, it will be understood that various omissions, substitutions,and changes in the form of the detail of the apparatus as illustrated aswell as the uses thereof, may be made by those skilled in the art,without departing from the spirit of the invention.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment. Thus, appearances of the phrases “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily all referring to the same embodiment. Furthermore, theparticular features, structures or characteristics of any embodimentdescribed above may be combined in any suitable manner, as would beapparent to one of ordinary skill in the art from this disclosure, inone or more embodiments.

Similarly, it should be appreciated that in the above description ofembodiments, various features of the inventions are sometimes groupedtogether in a single embodiment, figure, or description thereof for thepurpose of streamlining the disclosure and aiding in the understandingof one or more of the various inventive aspects. This method ofdisclosure, however, is not to be interpreted as reflecting an intentionthat any claim require more features than are expressly recited in thatclaim. Rather, as the following claims reflect, inventive aspects lie ina combination of fewer than all features of any single foregoingdisclosed embodiment. Thus, the claims following the DetailedDescription are hereby expressly incorporated into this DetailedDescription, with each claim standing on its own as a separateembodiment.

1. (canceled)
 2. A method of delivering suture portions to an opening ina heart wall of a patient, the method comprising: delivering a suturingsystem through the heart wall, wherein the suturing system comprises: asuturing device comprising an elongate body having a proximal end and adistal end, the suturing device having a distal section that extendsthrough the heart wall and into the heart once the suturing system isdelivered, the suturing device comprising a plurality of arms positionedoutside of the heart and a plurality of needles positioned inside theheart once the suturing system is delivered; a first sheath positionedover the suturing device, a distal end of the first sheath beingproximal to the plurality of arms once the suturing system is delivered;and a second sheath positioned over the first sheath; extending theplurality of arms from the elongate body of the suturing device, each ofthe arms carrying a suture portion having a suture end releasablyretained in a respective arm, wherein each suture portion extends fromits respective arm proximally between the first sheath and the secondsheath to a location outside of the patient; positioning the pluralityof arms against the outside surface of the heart; advancing theplurality of needles from the elongate body through the heart wall, eachneedle aligned with a respective arm and engaging a respective sutureend carried by the respective arm; retracting the plurality of needlesthrough the heart wall to draw the respective suture ends through theheart wall; retracting the arms into the elongate body of the suturingdevice while maintaining a distal section of the elongate body withinthe heart; advancing the first sheath positioned around the elongatebody into the opening in the heart wall; and withdrawing the elongatebody from the heart wall while leaving the first sheath within the heartwall, the withdrawing of the elongate body drawing the suture endsengaged by the needles through a lumen of the first sheath to a locationoutside of the patient.
 3. The method of claim 2, further comprisingremoving the second sheath from around the first sheath afterwithdrawing the elongate body.
 4. The method of claim 2, furthercomprising joining a pair of suture portions extending through the firstsheath, thereby forming a single suture.
 5. The method of claim 4,further comprising pulling on one or both of the remaining free ends ofthe single suture to remove the single suture from the first sheath andprovide a continuous length of suture extending into the heart andacross the opening in the heart wall.
 6. The method of claim 5, furthercomprising attaching a pledget to one or both of the suture portionsbefore joining the pair of suture portions, wherein pulling on one orboth of the remaining free ends comprises pulling on one of the freeends until the pledget enters the heart.
 7. The method of claim 5,further comprising performing one or more procedures on the heart withthe suture extending into the heart and across the opening of the heartwall.
 8. The method of claim 7, further comprising using said suture toclose the opening in the heart wall after the one or more procedures onthe heart are performed.
 9. The method of claim 5, further comprisingtightening the single suture while withdrawing the first sheath, therebyclosing the opening in the heart as the first sheath is withdrawn tosubstantially maintain haemostasis within the heart.
 10. The method ofclaim 2, wherein the plurality of arms comprises a first arm and asecond arm positioned approximately 180 degrees apart from the first armaround a circumference of the elongate body.
 11. The method of claim 2,further comprising attaching a pledget to one of the suture ends andpulling a suture portion such that the pledget is within the heart. 12.The method of claim 2, wherein the suturing device comprises four arms,and further comprising joining a first and second pair of sutureportions extending through the first sheath, thereby forming a pair ofseparate sutures.
 13. The method of claim 12, further comprisingattaching a first pledget to one of the sutures of the first pair ofsuture portions prior to joining the sutures of the first pair, andattaching a second pledget to one of the sutures of the second pair ofsuture portions prior to joining the sutures of the second pair.
 14. Themethod of claim 13, further comprising attaching the first pledget toone of the sutures of the second pair of suture portions prior tojoining the sutures of the first and second pairs, and attaching thesecond pledget to a separate one of the sutures of the first pair ofsuture portions prior to joining the sutures of the first and secondpairs.
 15. The method of claim 2, comprising, prior to delivering thesuturing system through the heart wall: delivering a trocar through apatient's chest to provide access to the thoracic cavity; delivering ahollow needle through the trocar and into the heart through a heartwall; delivering a guidewire through the trocar and through the hollowneedle into the heart; removing the hollow needle; wherein the suturingsystem is delivered through the trocar into the thoracic cavity and overthe guidewire into the heart.
 16. A method of performing a procedure onthe heart of a patient, the method comprising: delivering an elongatedevice through a heart wall such that the a distal section of the deviceis positioned within the heart; and removing fluid exiting the heartalong the distal section of the elongate device and through the heartwall, said removing of fluid comprising causing said fluid to flowthrough at least one opening positioned on the elongate device on anoutside of the heart to remove fluid that may accumulate between theoutside of the heart and the pericardial sac.
 17. The method of claim16, wherein fluid flows through the at least one opening by applyingnegative pressure to the at least one opening from outside of thepatient.
 18. The method of claim 16, wherein the elongate devicecomprises a distally facing surface in its distal section, anddelivering the elongate device comprises pushing the distal facingsurface against an outer surface of the heart.
 19. The method of claim18, wherein the elongate device comprises a plurality of openingsproximal to the distally facing surface.
 20. The method of claim 16,wherein the elongate device is a suturing device comprising a pluralityof arms and a plurality of needles, and further comprising: moving theplurality of arms from a first position wherein the arms are retractedwithin the elongate body to a second position wherein the arms each hasa free end extending away from the elongate device and are positionedadjacent an outer surface of the heart, each arm comprising at least onesuture mount at the free end releasably retaining a suture portion; andmoving a plurality of needles from a retracted position in which needlesare within the elongate device to a deployed position in which distalpoints of the needles extend out of the elongate device, through theheart wall and into a suture mount of a corresponding arm.
 21. Asuturing device for suturing an opening in a heart wall, comprising: anelongate body comprising a proximal end and a distal end, the distal endof the elongate body configured to be delivered through the heart wallinto a heart; a plurality of arms near the distal end, wherein each armis configured to move between a first position wherein the arm isretracted within the elongate body, and a second position wherein thearm has a free end extending away from the elongate body, each armcomprising at least one suture mount at the free end and configured toreleasably retain a suture portion, wherein each arm has a proximal sideconfigured to engage the pericardial sac as the arm moves from the firstposition to the second position, and each arm in its second position isconfigured to be positioned along an outer surface of the heart; and aplurality of needles, each needle configured to move between a retractedposition in which needle is within the elongate body to a deployedposition in which a distal point of the needle extends out of theelongate body and into a suture mount, wherein the needles areconfigured to pass through the heart wall when the arms are positionedalong an outer surface of the heart.
 22. The device of claim 21, whereinthe proximal side comprises a sharp edge configured to engage thepericardial sac.
 23. A method of suturing an opening in the heart of apatient, the method comprising: delivering a suturing device comprisingan elongate body through a heart wall such that a distal section of thedevice is positioned within the heart, the suturing device comprising aplurality of arms and a plurality of needles; and moving the pluralityof arms from a first position wherein the arms are retracted within theelongate body to a second position wherein the arms each has a free endextending away from the elongate body, wherein the arms engage thepericardial sac as they move to their second positions to move thepericardial sac away from an outer surface of the heart, each armcomprising at least one suture mount at the free end releasablyretaining a suture portion; and moving a plurality of needles from aretracted position in which needles are within the elongate body to adeployed position in which distal points of the needles extend out ofthe elongate body, through the heart wall and into a suture mount of acorresponding arm.
 24. A method of closing an opening in the heart withsutures, the method comprising: inserting four sutures through tissue ofa heart wall such that each suture has an end that runs through anopening in the heart and an end that runs outside of the heart, whereinthe four sutures comprise a first pair and a second pair of sutures, thesutures of the first pair positioned opposite each other with respect tothe opening in the heart and the sutures of the second pair positionedopposite each other with respect to the opening in the heart; attachinga first end of a first pledget to a first end of a first suture andattaching a first end of a second pledget to a first end of a secondsuture, wherein the first pair comprises the first suture and a thirdsuture with a first end, and the second pair comprises the second sutureand a fourth suture with a first end; securing together the ends of thefirst pair that run through the opening in the heart; securing togetherthe ends of the second pair that run through the opening in the heart;and pulling on at least one of the ends of each pair that run outside ofthe heart.
 25. The method of claim 24, further comprising attaching asecond end of the first pledget to the first end of the third suture andattaching a second end of the second pledget to the first end of thefourth suture, prior to securing together the ends of the first suturepair that run through the opening in the heart and the ends of thesecond suture pair that run through the opening in the heart.
 26. Themethod of claim 24, further comprising attaching a second end of thefirst pledget to the first end of the fourth suture and attaching asecond end of the second pledget to the first end of the third suture,prior to securing together the ends of the first suture pair that runthrough the opening in the heart and the ends of the second suture pairthat run through the opening in the heart.
 27. The method of claim 24,wherein the first end of each suture is the end that runs through theopening in the heart, and the end of each suture than runs outside ofthe heart is a second end.
 28. The method of claim 27, furthercomprising attaching a third pledget to the second ends of the first andfourth sutures and a fourth pledget to the second ends of the second andthird sutures.
 29. The method of claim 28, further comprising pushingthe third and fourth pledgets to a position adjacent an external wall ofthe heart.
 30. The method of claim 27, further comprising attaching athird pledget to the second ends of the first and third sutures and afourth pledget to the second ends of the second and fourth sutures. 31.The method of claim 30, further comprising pushing the third and fourthpledgets to a position adjacent an external wall of the heart.